The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition
For Two Decades, One Volume Has Offered Complete Coverage of the IVD Industry
The 16th edition of Kalorama’s Worldwide Market for In Vitro Diagnostic Tests is a must have for anyone interested or involved in the IVD industry. Having a guide for the state of IVD and its future is a vital part of making well-informed decisions. The 16th edition of Kalorama’s Worldwide Market for In Vitro Diagnostic Tests provides readers with reliable estimates, real-world forecasts, and insights needed to understand the IVD market in its entirety.
“Every significant test category in IVD is given a chapter with sub-segments. It’s like having ten market research reports in one.”
Published since 1999, this 1,500+ page report is based on vendor reporting, interviews, vendor activities, and more on a global scale. Kalorama’s full assessment of the IVD diagnostic market makes The Worldwide Market for In Vitro Diagnostics Tests the most trusted report by top companies in the industry.
The report has complete IVD market research sections with test segment estimates and forecasts in: Clinical Chemistry, Hematology, Histology, Company Profiles and Rankings, Molecular, Immunoassay, Infectious Disease, Coagulation, Blood Bank IVD, Point of Care. This is every significant segment in in vitro diagnostics.
WHAT’S WITHIN THE SEGMENT? Detail on Important Test Markets
The Worldwide Market for In Vitro Diagnostic Tests is the result of months of analysis and review of secondary sources by seasoned analysts, critical readings of current and historic company filings and releases, interviews with relevant experts and searching of government sources and journal literature. All test segments contain valuable information on current market size and future projection. Compound annual growth rate is provided, as well as significant IVD companies in the market and IVD manufacturer’s product innovations. This detailed look at the IVD market yields unparalleled global market modeling.
Why The Worldwide Market for In Vitro Diagnostic Tests?
- Maximum Value: One Report, All Segments, World Markets
- Published Since 1999, by an Expert Firm That Focuses on IVD and Related Healthcare
- Profiles of 300+ Companies in the Market, Detail on the Top 40
- Filled with Industry-Utilized and Business Planning Numbers
- Learn Who is Launching Products and Investing in the IVD Industry
- Overall IVD Markets for Every Significant Nation, Detail for Major Markets
- Based on Latest Financial Reporting, Real-World Industry and Medical Practice Trends This report gives you definitive answers to important questions, including:
- What is the Size of IVD Market Segments?
- Within Those Segments, How Do They Break Down?
- Where Will Those Markets be In Five Years?
- How Has the IVD Market Changed Over Time?
- Who’s Winning?
- Who’s Merged?
- Who’s Launched Game-Changing Products?
- What is the Competitive Landscape?
- Who Can I Partner With?
- Where are the Growth Markets I Can Enter or Buy Into?
- And More…
Country-Level Coverage
The in vitro diagnostics market is a global one, and this report reflects the international scope of the in vitro diagnostic market’s size. In the healthcare market, IVD companies sell globally and think globally.
“The 16th edition features the overall IVD market size for every significant world country, as well as details for major market segments.”
Trends in one part of the world affect IVD manufacturers’ product decisions and company financial performance in others.
The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama Information methodology. It is the result of months of painstaking work by experienced IVD industry analysts, who have tracked hundreds of in vitro diagnostic companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the current in vitro diagnostics industry.
Competitive Analysis and Corporate Profiling
The report concentrates hundreds of pages on detailed and tiered profiles of companies in the in vitro diagnostics market. The experience that Kalorama Information has in the IVD market is evident in its tiering and segmentation of companies.
“Profiles of IVD-relevant companies. No other resource comes close.”First tier, second-tier and specialist companies are profiled. Financial results, product launches, company history and strategic plans are analyzed in the profiles. Over 200 Profiles are included in the report.
- CHAPTER ONE: EXECUTIVE SUMMARY
- Figure 1-1: The Worldwide IVD Market, 2018, 2023 and 2028 ($billions)
- Figure 1-2: COVID-19 IVD Market Share, by Segment (Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care), 2022
- SCOPE AND METHODOLOGY
- SIZE AND GROWTH OF THE MARKET
- Table 1-1: Global In Vitro Diagnostic Sales by Product Market, 2023-2028 ($ million) (Clinical Chemistry; Immunoassays- Infectious disease, Other immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c - lab; Hematology - Core Lab; Microbiology (ID/AST); Microbiology (molecular); Coagulation; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular -NAT Screens; Circulating tumor cells; POC, OTC diabetes; Continuous Glucose, POC, OTC other; POC, professional/hospital; Mass Spectrometry) and COVID-19 Dx
- MARKET HIGHLIGHTS
- COMPETITIVE PICTURE IN IVD
- Figure 1-3: IVD Leaders, by Company (Abbott, Danaher, Roche, Siemens Healthineers)
- WHAT TO WATCH LONG-TERM
- China
- Emerging Market Growth
- Globalization, Climate Change
- FINDING WHAT YOU ARE LOOKING FOR IN THE 16TH EDITION
- Table 1-2: Finding What You Are Looking For in the 16th Edition
- CHAPTER TWO: INTRODUCTION
- IVD LANDSCAPE
- REPORT DESIGN
- Changes Between 15th and 16th Editions
- PAMA AND CMS
- MARKET ANALYSIS OF IVD MARKET SEGMENTS
- Table 2-1: Global In Vitro Diagnostic Sales by Product Market, 2023-2028 ($ million) (Clinical Chemistry; Immunoassays- Infectious disease, Other immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c - lab; Hematology - Core Lab; Microbiology (ID/AST); Microbiology (molecular); Coagulation; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular -NAT Screens; Circulating tumor cells; POC, OTC diabetes; Continuous Glucose, POC, OTC other; POC, professional/hospital; Mass Spectrometry) and COVID-19 Dx
- Figure 2-1: Developed vs. Developing IVD Market Shares, 2023 and projected 2028 (%)
- TOP SUPPLIERS AND NICHE PLAYERS
- Introduction
- Overview of the Top Tier Companies
- Table 2-2: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2022 and estimated 2023 ($ million)
- Abbott Diagnostics
- Roche Diagnostics
- Ventana Medical Systems/ Roche Tissue Diagnostics
- Danaher Corporation
- Cepheid
- Radiometer
- Beckman Coulter
- Siemens Healthineers
- Thermo Fisher Scientific
- Illumina
- Becton Dickinson & Co
- Dexcom
- bioMérieux
- Sysmex Corporation
- QuidelOrtho Corporation
- Exact Sciences
- Werfen
- Instrumentation Laboratory
- Inova Diagnostics
- Hologic
- Bio-Rad Laboratories
- Agilent
- DiaSorin Group
- QIAGEN N.V.
- Mindray
- Natera
- Overview of Selected Second Tier Companies
- Table 2-3: Revenues of Selected Top 20 Niche Players, 2022 and estimated 2023 ($ million, estimated)
- Bruker/CALID Group
- PerkinElmer (Revvity)
- Myriad Genetics
- Grifols S.A.
- BGI Genomics
- Guardant Health
- Sekisui Diagnostics
- Invitae
- Diagnostica Stago
- Fujirebio
- OraSure Technologies
- Eiken Chemical Co
- Nihon Kohden
- Fulgent Genetics
- Meridian
- Horiba/ABX
- Menarini Diagnostics
- Masimo
- Veracyte
- BioCartis
- THE IMPACT OF COVID FOR THE TOP TIER COMPANIES
- Figure 2-2: Top Tier Market Distribution, 2022 and 2023, estimated (%)
- IVD COMPANIES MERGERS & ACQUISITIONS
- Table 2-4: Selected IVD Mergers and Acquisitions 2019-2023 (first half)
- COLLABORATION, PARTNERSHIP, ALLIANCE AGREEMENTS
- Table 2-5: Selected IVD Partnerships/Collaborations/Alliance Agreements, 2016-2019
- TEST SERVICES
- Table 2-6: Selected Test Services, Sales, by Company (Exact Sciences Corp. Myriad Genetics, NeoGenomics), 2017-2022 ($ millions, estimated where applicable)
- Table 2-7: Global Lab Market Segmentation, by Segment (Hospital and Acute Care Labs, Independent Labs, Physician Office Labs), 2022 ($ billions)
- Table 2-8: Clinical Laboratory Revenues for Selected of U.S.-based Reference Labs, by Company (Bio-Reference Lab/OPKO, Labcorp, Quest Diagnostics), 2017-2022 ($ million, estimated)
- Table 2-9: Estimated Clinical Test Volume, by Select Independent Laboratory (Bio-Reference Lab/Opko, Eurofins Scientific, Labcorp, Medicover, NeoGenomics, Quest Diagnostic, Sonic Healthcare, Unilabs), 2022 (millions of units)
- Table 2-10: Estimated COVID-19 Test Volume, by Select Independent Laboratory (Bio-Reference Lab/Opko, Eurofins Scientific, Labcorp, Medicover, Medicover, NeoGenomics, Quest Diagnostic, Sonic Healthcare, SynLab, Unilabs), 2022 (millions of units)
- HISTORICAL IVD MARKET VS TODAY
- In the Beginning to Now
- Figure 2-3: Share of IVD Market by Segment, Percentage, 2000 and 2023 Compared (Clinical Chemistry, Hematology, Coagulation, Immunoassays, Microbiology (ID/AST), POC Diabetes, POC - Other, Histology/Cytology, Molecular, Blood Banking [imm & typing], Others)
- Future
- Next-Generation Sequencing
- Cancer Testing (Liquid Biopsy)
- Companion Diagnostics
- POINT OF VIEW
- Figure 2-4: IVD Market, by Segment (Clinical Chemistry; Immunoassays- non isotopic: Infectious disease, immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c – lab; Hematology – Core Lab; Microbiology (ID/AST); Microbiology [molecular]; Microbiology – Mass Spectrometry; Coagulation [PT/INR]; Coagulation, molecular; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular – NAT Screens; Circulating tumor cells; POC, OTC diabetes; POC, OTC other; POC, professional/hospital; Mass Spectrometry), 2019 Compared to 2023 (%)
- COVID-19 IMPACT AND SUMMARY
- Figure: 2-5: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments, 2020-2028 ($ million)
- COVID-19 Market Value
- Table 2-11: COVID-19 Market Share, by Segment (Immunoassay, Molecular, Rapid – POC), 2023 (%)
- Figure 2-6: IVD COVID-19 Market, Distribution by Region (North America, Europe, Asia Pacific, RoW), 2023 (%)
- CHAPTER THREE: THE GLOBAL PICTURE FOR IN VITRO DIAGNOSTIC MARKETS
- BACKGROUND
- Simultaneous Threats: Chronic and Acute
- Expected World IVD Market Developments
- GLOBAL POPULATION AND AGING
- Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billions)
- Figure 3-2: Global Population Distribution, 2022
- Table 3-1: Elderly Support Ratio in Various Countries (Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World), 2010 vs. 2050
- Workforce Reduction
- Table 3-2: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World) 2020
- WHO ESSENTIAL IVD LIST
- Table 3-3: WHO Model List of Essential In Vitro Diagnostics (EDL)
- Increase in Chronic Diseases
- Figure 3-3: Leading Causes of Death Globally, 2019
- COVID-19
- Table 3-4: Selected Molecular EUA Tests for COVID-19
- Table 3-5: Selected Antigen Immunoassay Tests for SARS-CoV-2
- Table 3-6: Individual EUAs for Serology Tests for SARS-CoV-2
- Table 3-7: Individual EUAs For IVDs for Management of COVID-19 Patients
- EMERGING AND EMERGED MARKETS
- Table 3-8: Market Potential by Total Population, and Percent Urban 2020 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia)
- SIZE AND FORECAST FOR THE GLOBAL IVD MARKET
- Table 3-9: Global In Vitro Diagnostic Market; Major Country/Region Markets, 2023 and 2028 ($ millions) (United States, EU 15/W. Europe, Japan, China, Canada, India, Eastern Europe, Brazil, Peru, Mexico, Saudi Arabia, Turkey, UAE, Vietnam, Russia, South Africa, South Korea, Australia, ROW)
- Table 3-10: Global In Vitro Diagnostic Market; Regional Markets, 2023 and 2028 ($ millions) (Africa, North America, Europe, Asia Pacific, Latin America, Middle East)
- Table 3-11: Global In Vitro Diagnostic Market – YOY Growth, 2022-2023
- Table 3-12: Global In Vitro Diagnostic Market; Regional Markets, 2022-2023 YOY Change (North America, Europe, Asia Pacific, Latin America, Middle East, Africa)
- THE IVD MARKET IN THE UNITED STATES
- Table 3-13: United States IVD Market Share by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Nucleic Acid Assays, Coagulation, Histology, Hematology, Blood Grouping, Others), ($ millions)
- PAMA and Reimbursement Changes
- Impact of CARES Act on PAMA
- Table 3-14: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2026
- LDT Update
- Changes Resulting from COVID-19 Pandemic
- Precision Medicine and NGS
- IVD MARKET IN EUROPE: GROWING MARKETS
- Table 3-15: Economic Indicators (GDP Growth, Inflation Growth), by Select European Country (Germany, France, Italy, Spain), 2020-2023 (%)
- Figure 3-4: International Monetary Fund Inflation Map, Global 2023
- Table 3-16: Western European IVD Market by Country, 2023 ($ millions, estimated) (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK)
- EU Regulation
- Table 3-17: IVD Market Per Capita, Europe, 2021/2022 Estimates (Switzerland, Germany, Netherlands, Sweden, France, Slovenia, United Kingdom, Italy, Spain, Slovakia, Greece, Croatia, Czech Republic, Hungary, Poland, Romania, Bulgaria, Russia, Ukraine)
- Precision Medicine in Europe
- Brexit
- JAPAN
- Table 3-18: Japan IVD Market by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
- EASTERN EUROPE: GROWTH REGION
- Table 3-19: Eastern European IVD Market, by Country, 2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other)
- Figure 3-5: Eastern Europe IVD Market, by Country, 2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
- CHINA: CURRENT IVD MARKET
- Table 3-20: China IVD Market by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
- Table 3-21: Total Midyear Population, by Broad Age Group: China (million persons), 2010-2050
- Clinical Laboratory Market in China
- IVD Distribution in China
- INDIA: POPULATION AND OPPORTUNITY
- Table 3-22: India IVD Market by Segment, 2023 (%) (Clinical Chemistry, Hematology, Coagulation; Microbiology; POC Diabetes; POC Other; Immunoassay; Histology; Others)
- Clinical Laboratory Market in India
- IVD Regulation
- REST OF ASIA
- Table 3-23: Asia Pacific IVD Market by Country, 2023 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)
- BRAZIL
- Table 3-24: Brazil IVD Market by Broad Segment, 2023 (%) (Clinical Chemistry, Microbiology, POC Diabetes, POC Other, Immunoassay, Histology, Others)
- Disease Trends
- Clinical Laboratory Market in Brazil
- IVD Regulation
- MEXICO
- Table 3-25: Mexico IVD Market by Broad Segment, 2023 (%) (Clinical Chemistry, Microbiology, POC, Immunoassay, Histology, Others)
- THE RUSSIAN FEDERATION
- CANADA
- EMERGING MARKETS
- Saudi Arabia IVD Market
- South Africa IVD Market
- South Korea IVD Market
- Turkey IVD Market
- United Arab Emirates (UAE) IVD Market
- Other Markets to Watch
- IVD MARKET OPPORTUNITY BY COUNTRY
- Table 3-26: IVD Market Opportunity by Country, 2023 Market Rank, Country CAGR 2023-2028 (China, Philippines, Brazil, Israel, Malaysia, India, Mexico, Indonesia, Chile, Poland, Saudi Arabia, South Korea, Romania, Colombia, United Arab Emirates, Argentina, Hungary, Vietnam, Iraq, Peru, Japan, France, Turkey, Egypt, Singapore, Luxembourg, Croatia, Jordan, U.S., Germany, United Kingdom, Canada, Spain, Russia, Netherlands, Switzerland, Belgium, Sweden, Austria, Denmark, Ireland, Finland, Iran, Thailand, Venezuela, Italy, Australia, Portugal, Greece, Czech Republic, South Africa, Norway, Bulgaria, Slovakia, Slovenia)
- Figure 3-6: IVD Market Opportunity by Country: Top 20 Markets (Country Market Value in $millions), Country CAGR 2023-2028 (%) (United States, Germany, Japan, France, United Kingdom, Italy, Canada, Spain, Australia, Brazil, Russia, India, Switzerland, Netherlands, Poland, Turkey, Sweden, Belgium, Mexico)
- CHAPTER FOUR: COMPANY AND INDUSTRY TRENDS
- INTRODUCTION
- Advanced Medicine Without Borders
- Table 4-1: Key Emerging IVD Markets, by Country (Brazil, Russia, India, China, South Korea, Mexico, Turkey, Vietnam) 2018-2023 ($millions)
- China Market Information
- Direct to Consumer Genetic Test Services
- Future Trends
- GENE EDITING
- Table 4-2: Selected Gene Editing / CRISPR Innovations
- CRISPR as a Diagnostic Tool
- CRISPR and the Food Industry
- MICROBIOME
- Table 4-3: Selected Microbiome Test Innovations
- NEXT GENERATION SEQUENCING
- Table 4-4: Selected Clinical NGS Platforms on the Market
- Liquid Biopsy
- Quality Assurance
- Product News
- Market Cleared Products
- Liquid Biopsy in Microbiology
- Liquid Biopsy Companies in 2021-2023
- The Future for Liquid Biopsy
- INFORMATION TECHNOLOGY ADVANCES AND ARTIFICIAL INTELLIGENCE
- AI in Clinical Practice
- Table 4-5: Selected AI Market Cleared Tests
- The Regulatory Pathway
- Product Initiatives
- Table 4-6: Selected AI Product Initiatives in Development and Collaborations
- AI IN LIQUID BIOPSY
- Table 4-7: Selected AI/Liquid Biopsy Initiatives
- Future Trends
- EXOSOME SEQUENCING
- BIOTIN INTERFERENCE IN IMMUNOASSAY DETECTION ERRORS
- Table 4-8: Biotin-free Offerings Currently on the Market
- TRAUMATIC BRAIN INJURY AND IVD
- PERSONALIZED MEDICINE
- TELEHEALTH
- Telehealth eMed to Implement Home Test to Treat Program
- BLOCKCHAIN
- SUBSTANCE ABUSE
- Opioid Epidemic
- COVID-19 and Substance Abuse
- Biomarkers and Substance Abuse
- Clinical Laboratory Testing for Drugs of Abuse
- Table 4-9: Global Drug Abuse Statistics
- Urine
- Blood
- Oral
- Hair
- Table 4-10: Selected Opioid Test FDA Approvals
- SALIVA TESTING
- BREATH TEST ADVANCES
- Table 4-11: Selected Disease Markers in Exhaled Breath
- MICRO-HOSPITAL OPPORTUNITIES
- CLIMATE CHANGE AND INFECTIOUS DISEASE
- KICKBACK SCHEMES
- EARLY SEPSIS DETECTION
- STAFFING SHORTAGES
- CHAPTER FIVE: POINT-OF-CARE TESTS
- OVERVIEW AND TRENDS
- POC INDUSTRY DRIVERS
- Patient focused drivers
- Medical/Healthcare related drivers
- Technology drivers
- Economic drivers
- Other drivers
- POC INDUSTRY CHALLENGES
- REGULATORY CHALLENGES
- PROFESSIONAL POC
- Table 5-1: Professional POC Test Sales by Category, Worldwide 2023 -2028 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
- Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing)
- OTC SELF TESTING
- Table 5-3: POC Self-Test Sales by Category, Worldwide, 2023-2028 ($million) (Glucose, Self; Glucose, Continuous; Pregnancy; Coagulation; Fecal Occult Blood; Drugs of Abuse; H. pylori; HIV; Cholesterol; Urinalysis; Other [TSH, Allergy, Autoimmune, etc.])
- HOME COLLECTION TREND
- Table 5-4: Home Collection Test Market, 2022 and 2027 ($million), CAGR 2022-2027
- Table 5-5: Home Collection Test Kit Market by Category, Worldwide, 2022 (% Estimated Share)
- Table 5-6: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
- PREGNANCY/FERTILITY TESTS
- Table 5-7: POC Pregnancy and Fertility Test Market Distribution by End User, 2023 (%) (OTC, PRO)
- Table 5-8: Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2023 (United States, Europe, Japan, RoW)
- COLON CANCER SCREENING
- Table 5-9: Selected POC Colon Cancer Tests
- Table 5-10: Colon Cancer POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
- LIPID TESTING
- Table 5-11: Lipid POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
- DRUGS OF ABUSE TESTING
- Table 5-12: POC Drugs of Abuse Test Sales Distribution by Setting, 2023 (%) (Employment Screening, Criminal Justice, Critical Care - Traditional POC)
- Products
- Table 5-13: Drugs of Abuse Tests on the Market
- RAPID AND POC INFECTIOUS DISEASE TESTING
- Table 5-14: Innovations in Molecular POC Infectious Disease Diagnostics
- Products
- HIV and Hepatitis Testing and Monitoring
- Tuberculosis
- Tropical and Neglected Diseases
- Respiratory Diseases
- Sepsis and Nosocomial Disease
- Sexual Health
- Lyme Disease
- Table 5-15: Innovations in Molecular POC Infectious Disease Diagnostics
- COVID-19
- Market Size and Growth
- Table 5-16: Infectious Disease POC Test Demand by Type, 2023 (%) (Influenza, HIV, STD, Hepatitis, Malaria, C.Difficile, E.coli, H.pylori, Home Test/OTC, Others)
- Table 5-17: Infectious Disease POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
- DIABETES TESTING – BLOOD GLUCOSE MONITORING
- Table 5-18: Glucose POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
- Figure 5-1: POC Glucose Testing Market Growth by Category, 2023-2028
- IT to Aid Diabetes Management
- Table 5-19: Selected Apps and Glucose Management IT
- Diabetes Market Analysis
- Table 5-20: Global Diabetes Sales by Test Category, 2023-2028 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
- POC Glucose Competitors
- Table 5-21: POC Test Revenues of Selected IVD Glucose Companies, 2023 ($ million, estimated)
- Blood Glucose Self-Testing
- Table 5-22: Selected Glucose Self-Test Meter Innovations
- Noninvasive Testing Devices
- Table 5-23: Selected Noninvasive Glucose Monitoring Devices
- Continuous Glucose Monitoring
- Table 5-24: Selected Continuous Blood Glucose System Developments
- Blood Glucose Testing by Professionals
- Table 5-25: Selected Innovations in Hospital-based Glucose Monitoring
- Diabetes Testing – Glycated Hemoglobin
- Table 5-26: Global HbA1c Test Sales Market and Distribution by Setting, 2023-2028 ($ millions) (HbA1c POC, HbA1c Lab)
- Table 5-27: Selected POC HbA1c Devices
- Genes and Other Markers of Diabetes
- Table 5-28: Selected POC Diabetes Monitoring Tests
- THE MAJOR POC TEST PLAYERS
- Table 5-29: POC Test Revenues of Selected IVD Companies, 2023 ($ million, estimated)
- CHAPTER SIX: THE CORE LAB
- CORE LAB OVERVIEW AND TRENDS
- Table 6-1: Selected Analytes for the Core Lab
- CONNECTIVITY
- OVERVIEW OF CHEMISTRY TESTS
- Lab Automation
- MARKET ANALYSIS
- Table 6-2: Global Clinical Chemistry Sales by Test Category, 2023-2028 ($millions) (General Chemistries, Blood Gases, Urinalysis)
- Table 6-3: Global Clinical Chemistry Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 6-4: Major Clinical Chemistry Companies, 2023 ($millions) (Blood gas/electrolyte, general chemistries, UA)
- Table 6-5: Selected Clinical Chemistry Innovations
- Rapid Response Systems
- Table 6-6: Selected Major Whole Blood Chemistry Analyzers
- Critical Care Analysis
- Table 6-7: Blood Gas, Electrolyte and Critical Care Instrument Market by End User, 2023 and 2028 (Lab-based, POC-based) (in $ millions)
- Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2023 (percent distribution of total sales)
- User Apps
- Table 6-9: Selected Apps, Critical Care and Urinalysis IT Innovations
- Urinalysis
- Table 6-10: UA Market by End User, 2023 and 2028 (Lab-based, POC-based)
- Table 6-11: Urinalysis Systems (including POC) Market Leaders, 2023 (percent distribution of total sales) estimated
- Table 6-12: Selected Urinalysis Innovations
- THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS
- CHAPTER SEVEN: IMMUNOASSAYS
- OVERVIEW AND TRENDS
- Immunoassay Technology Continues to Evolve
- Table 7-1: Selected Immunoassay Technologies
- Mass Spectrometry
- Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
- Radioimmunoassays
- MARKET ANALYSIS
- Leading Suppliers and Growth Potential
- Table 7-3: Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2023-2028 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
- Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2023 (%) (North America, Europe, Japan, Asia Pacific, RoW)
- Table 7-5: IVD Quality Control Market (estimated), 2023 ($millions)
- Table 7-6: Selected Immunoassay Quality Control Products
- Table 7-7: 2022-2023 Revenues of Leading Lab-based Immunoassay Vendors (in millions $), Estimated
- MATURE ASSAY SEGMENT
- Thyroid Function
- Therapeutic Drug Monitoring
- Vitamin D
- Table 7-8: Selected Vitamin D Immunoassays
- Anemia
- Toxicology/DAU
- Allergy
- MATURING IMMUNOASSAYS
- Proteins
- GROWTH IMMUNOASSAYS
- Tumor Markers
- Table 7-9: Selected Tumor Marker Innovations
- Cardiac Markers
- Table 7-10: Selected Cardiac Marker Innovations
- Autoimmune
- Table 7-11: Selected Autoimmune Test Innovations
- Rheumatoid Arthritis
- Table 7-12: Selected Arthritis Immunoassay Innovations
- Gastrointestinal Disorders
- Table 7-13: Selected Inflammatory Bowel Disease Test Innovations
- Transplant Management
- Table 7-14: Selected Immunoassays for Transplant Medicine
- Women’s Health
- Table 7-15: Selected Women’s Health Innovations
- Alzheimer’s Disease
- Table 7-16: Selected Innovations for Alzheimer’s Disease Immunoassays
- Traumatic Brain Injury
- Sleep Apnea
- Miscellaneous
- Table 7-17: Selected Immunoassay Innovations
- Point-of-Care OTC and Professional Use Immunoassays
- Table 7-18: Global POC Immunoassay Sales Distribution by Region, 2023 (United States, Europe, Japan, RoW)
- Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2023-2028 (millions $) (OTC/Self Tests: Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Infectious Disease/COVID-19, Other, OTC/Self Total; professional POC: Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Infectious Disease/COVID-19, Other, Professional Total)
- Table 7-20: Selected Self-Test Immunoassay Innovations
- Pregnancy Testing
- Cardiovascular Diagnostics
- Drugs of Abuse/Therapeutic Drug Monitoring
- INNOVATING POC
- Table 7-21: Selected POC Test Innovations
- Table 7-22: Selected POC Immunoassay Test Platforms
- THE COMMERCIAL OUTLOOK FOR IMMUNOASSAYS
- CHAPTER EIGHT: MOLECULAR ASSAYS
- OVERVIEW
- Table 8-1: Common Next Generation Molecular Test Traits
- SAMPLE PREPARATION AND QUALITY CONTROL
- Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations
- MOLECULAR EVOLUTION
- Exosome Sequencing
- Table 8-3: Selected Exosome Test Innovations
- Liquid Biopsy
- Table 8-4: Selected Liquid Biopsy Innovations
- Metabolomic Profiling
- Information Technology
- Table 8-5: Selected IT Innovations in Molecular Diagnostics
- Artificial Intelligence AI
- Forensic Studies – An Emerging Opportunity
- Table 8-6: Selected Innovations in Forensic DNA Testing
- Test Platforms
- Table 8-7: Key Molecular Technologies and Major Players
- Table 8-8: Selected Molecular Test Platform Innovations
- MAJOR PLAYERS
- Table 8-9: Molecular Test Revenues of Selected IVD Vendors, by Company (Agilent, bioMérieux, Cepheid, Exact Sciences, Hologic, Illumina, Myriad Genetics, QIAGEN, Roche, Thermo Fisher) 2018-2022, 2023 estimated (in millions $)
- MARKET ANALYSIS
- Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales by Type with NIPT, 2023-2028 (in millions $)
- Oncology
- Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 8-12: Selected Molecular Tumor Marker Test Innovations
- Inherited Diseases and Thrombophilia SNPs
- Table 8-13: Most Frequently Requested Genetic Tests
- Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 8-15: Selected Genomic Tests for Inherited Diseases
- Depression and Psychiatric Disorders
- Prenatal and Newborn Testing
- Table 8-16: Global Prenatal Test Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 8-17: Selected Prenatal Services Provided
- Table 8-18: Selected Molecular Tests for Prenatal Analysis
- Transplant Diagnostics
- Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
- THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS
- CHAPTER NINE: HEMATOLOGY
- OVERVIEW OF HEMATOLOGY AND TRENDS
- Table 9-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2023 estimated
- Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution (%)
- Digital Image Analysis
- Table 9-3: Selected Hematology Image Analysis Innovations
- Digital Evolution
- Quality Control Measurement Programs
- Table 9-4: Selected Quality Control Hematology FDA Registrations, 2023
- LABORATORY-BASED HEMATOLOGY TESTING
- Table 9-5: Selected Hematology Innovations, 2014-2023
- Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2023 and 2028 ($ millions)
- Regional Laboratory-based Hematology Test and Instrument Market
- Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- DECENTRALIZED HEMATOLOGY TESTING
- Hemoglobin/Hematocrit at the POC
- Table 9-8: POC Hematology Distribution by Specialty (hematocrit/hemoglobin vs. other routine hematology (WBC, erythrocyte, platelet)
- Table 9-9: Selected POC Hemoglobin and Hematocrit Systems
- Table 9-10: Selected POC Hematology Analyzer Systems
- Table 9-11: Decentralized Hematology Test and Instrument Market, 2023 and 2028 ($ millions) (Instruments, lab-style; Handheld devices)
- MARKET ANALYSIS: LEADING SUPPLIERS
- Table 9-12: Top Hematology Company Revenues (laboratory and POC), by Company (Abbott, Beckman Coultar/Danaher, Roche, Siemens, Sysmex), 2023 ($ millions)
- Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS
- CHAPTER TEN: COAGULATION
- OVERVIEW AND TRENDS OF COAGULATION AND IMMUNOHEMATOLOGY TESTS
- SPECIAL TOPICS
- COVID-19
- Direct Oral Anticoagulants (DOACs)
- Table 10-1: Select Major Anticoagulant Sales, by Drug (Apixaban, Rivaroxaban), 2022
- D-dimer
- Table 10-2: Global D-dimer Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW) (%)
- MARKET ANALYSIS
- Table 10-3: Global Coagulation Sales by Segment, 2023-2028 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
- Table 10-4: Global Coagulation Test and Instrument Market by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- LAB-BASED TESTING
- Table 10-5: Selected Lab-based Coagulation Innovations
- Genetic Markers of Hypercoagulopathies
- Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2022
- Table 10-7: Global Molecular - Thrombophilia SNP Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Table 10-8: Selected Molecular Coagulation Test Innovations
- LEADING SUPPLIERS: LABORATORY SYSTEMS
- Table 10-9: Top Coagulation Company Revenues, Laboratory-based, by Company (Diagnostica Stago, Instrumentation Laboratory [Werfen], Siemens Healthineers, Sysmex), 2023 ($ millions) est.
- DECENTRALIZED COAGULATION TESTING – PROFESSIONAL USE
- Decentralized Coagulation Testing – OTC
- Table 10-10: Selected POC Coagulation Test Innovations
- Platelet Testing
- Table 10-11: Selected Platelet Activity Test Innovations
- LEADING SUPPLIERS: POC SYSTEMS
- Table 10-12: Top Coagulation Company Revenues, POC, 2023 ($ millions) est.
- THE COMMERCIAL MARKET FOR COAGULATION TESTS
- Table 10-13: Major Anticoagulants Uses and Tests
- CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
- THE REAL IMPACT OF INFECTIONS
- Herpes and Alzheimer’s Disease
- Ebola and Cancer
- HIV and Cancer
- H pylori and Cancer
- Bacteria and Parkinson's
- HPV and Cancer
- MICROBIAL ANTIBIOTIC RESISTANCE – THE ROLE OF CLINICAL TESTS
- Fast Identification
- Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
- TRADITIONAL MICROBIOLOGY AND ITS LIMITS
- THE NEW MICROBIOLOGY - INNOVATIONS
- Liquid Based Microbiology and Automation Innovations
- Post-Blood Culture Microbial ID
- PCR and Other NAAT-Based Tests for Infectious Diseases
- Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
- Microbiome-Related Microbiology Tests
- Illumina
- Bio-Rad
- QIAGEN
- Luminex (DiaSorin)
- inBiome BV
- DNA Genotek
- Abbott
- Thermo Fisher Scientific
- Table 11-3: Selected Microbiome-Based Tests
- Next Generation Sequencing-Based Microbiology Approaches
- Table 11-4: Selected Companies Applying DNA/RNA Sequencing to Microbiology
- Syndromic/Multiplex Testing
- NEW INFECTIOUS DISEASE THREATS
- Table 11-5: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
- Tickborne Diseases (TBDs)
- Zika
- Chagas
- Dengue
- Ebola
- Chikungunya
- Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
- Marburg
- SARS-CoV-2 (COVID-19)
- Figure 11-1: Total COVID-19 Test Volume by Country, Average Estimates June-August 2023 (Thousands)
- Figure 11-2: Estimated Market Distribution, COVID-19 Test Value, 2023
- Monkeypox
- MARKET ANALYSIS
- Table 11-6: Global Microbiology Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- MARKET ANALYSIS - TRADITIONAL MICROBIOLOGY ID/AST
- Table 11-7: Global Microbiology ID/AST Market, 2023-2028 (in millions USD) (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, Rapid Microbiology; ID/AST Supplies)
- Table 11-8: Global ID/AST Testing Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Traditional ID/AST
- Table 11-9: Global ID/AST Testing, Distribution by Systems, (%) (Panel, Auto)
- Blood Culture
- Table 11-10: Selected Advanced Techniques in Positive Blood Culture
- Chromogenic Media
- Rapid Tests Performed on Colonies from Culture Media
- Supplies
- MARKET ANALYSIS - MICROBIOLOGY IMMUNOASSAYS
- Improvements in Microbiology Immunoassays
- Table 11-11: Selected Infectious Disease Immunoassay Innovations
- Table 11-12: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2023 (in $ millions) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Lyme disease, Other, COVID-19) est.
- Table 11-13: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution (by %) by Region, 2023 (North America, Europe, Asia Pacific, RoW)
- Hepatitis Testing
- Sepsis
- HIV Immunoassay Testing
- Table 11-14: Selected HIV Assays
- Sexually Transmitted Diseases (STDs)
- ToRCH
- Lyme Disease
- TBD-Serochip (Roche associated)
- Rapid Immunoassay Tests
- Table 11-15: Global Rapid Immunoassay Testing Market, Sales Distribution by Pathogen, 2023 (%) (Influenza, HIV, STD, Hepatitis, Malaria, C.Difficile, E.coli, H.pylori, Home Test/OTC, Others)
- MARKET ANALYSIS - MOLECULAR MICROBIOLOGY
- Table 11-16: Global Molecular Microbiology Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
- Table 11-17: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2023-2028 (in $ millions) (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, Others, COVID-19; Blood Bank Screening)
- Lab Automation and Molecular Diagnostics
- Table 11-18: Selected Automated Molecular Test Instrument Platforms
- Molecular Respiratory Infection Testing
- The Respiratory Trio – Flu, Strep, RSV
- Table 11-19: Selected COVID-19, Flu, RSV Tests
- Molecular Testing for Sexually Transmitted Diseases
- Molecular Hepatitis Testing
- Molecular HIV Testing
- Table 11-20: Innovations in Molecular POC Diagnostics for HIV
- Molecular Tests for Hospital-Acquired Infections (HAIs)
- Table 11-21: Frequency of the Most Common Nosocomial Infections
- Assessing the Problem: Nosocomial Infection Statistics
- Clostridium Difficile
- MRSA
- Molecular TB Testing
- Limitations of Molecular Microbiology Testing
- MASS SPECTROMETRY
- Table 11-22: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
- THE FUTURE OUTLOOK FOR MICROBIOLOGY
- CHAPTER TWELVE: BLOOD BANKING SERVICES
- OVERVIEW
- The Current Status of Global Blood Collection
- GLOBAL BLOOD SAFETY
- Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV, Chagas, Malaria, HTLV I/II)
- Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
- Zika Virus
- Blood and Component Collection
- Table 12-3: Blood Component Usage for Selected Conditions
- Table 12-4: Red Blood Cell and Platelet Use by Hospital Services (%)
- COVID-19 Impact on Plasma Collection
- Reevaluating Blood Transfusions
- Table 12-5: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
- BLOOD TYPING AND GROUPING MARKET
- Manual Blood Typing Methods
- Automated Blood Typing and Screening Methods
- Molecular Methods
- Table 12-6: Selected Blood Typing and Grouping Innovations
- Size and Growth of Typing Markets
- Table 12-7: Global Blood Typing Market, 2023-2028 (Typing) (in $ millions)
- Blood Typing Market by Geography
- Table 12-8: Global Blood Typing Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
- BLOOD TESTING MARKET
- Table 12-9: Selected Blood Testing Innovations
- Preventing Bacterial Infections
- Immunoassays
- Nucleic Acid Testing (NAT)
- Size and Growth of the Market
- Table 12-10: Global Blood Banking Diagnostics Market, 2023-2028 (Immunoassay Screen, NAT Screens) (in $ millions)
- Blood Testing Market by Geography
- Table 12-11: Global Blood Testing Market by Geography, 2023 (%) (North America, Europe, Asia Pacific, RoW)
- THE COMMERCIAL OUTLOOK FOR BLOOD BANKING TESTING
- CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
- OVERVIEW
- SPECIAL TOPICS
- Histology Automation
- Table 13-1: Selected Histology Lab Automation
- Table 13-2: Histology Information Technology Tools
- Advanced Analysis Solutions
- Table 13-3: Selected Advanced Histology Techniques
- HPV meets Core Lab
- Table 13-4: Global HPV Test Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
- Table 13-5: Selected HPV Test Innovations
- MARKET ANALYSIS
- Total Market
- Table 13-6: Global Histology/Cytology Sales by Type, 2023-2028 ($ millions) (Pap Tests, in situ hybridization, immunohistochemistry, traditional non-Pap stains, HPV, TOTAL; Digital Imaging, CTCs, Flow Cytometry)
- Regional Market Analysis
- Table 13-7: Global Histology/Cytology Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
- Table 13-8: Revenues of the Major Histology Companies, 2018-2023 ($ millions, estimated)
- Traditional Stains
- Table 13-9: Selected Vendors of Traditional Histology Stains
- Pap Testing
- Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2021
- Immunohistochemistry and In Situ Hybridization
- Table 13-11: Selected In Situ Hybridization-based Tests
- Table 13-12: Selected IHC Test Innovations
- Pharmacodiagnostic Histology
- Table 13-13: Major Pharmacodiagnostic Markers
- Table 13-14: Selected Pharmacodiagnostic Histology Tests
- Digital Imaging and Computational Pathology
- Table 13-15: Selected Digital Pathology Image Capture and Viewing Solutions
- COVID-19 and Digital Pathology
- Table 11-16: FDA Digital Pathology Device Review Classification During COVID-19
- Table 13-17: Selected Digital Imaging Innovations
- Circulating Tumor Cells
- Table 13-18: Selected Innovations in CTC Technology
- Flow Cytometry
- THE COMMERCIAL OUTLOOK FOR HISTOLOGY AND CYTOLOGY TESTS
- CHAPTER FOURTEEN: COMPANY PROFILES: THE TOP TIER
- ABBOTT DIAGNOSTICS
- Table 14-1: Abbott Diagnostics Revenue History ($ million)
- Table 14-2: Abbott Diagnostic Revenues by Segment, 2017-2022 ($ million) est.
- Core Lab
- Hematology
- Blood Banking
- Infectious Diseases - Molecular
- Diabetes
- HIV Point of Care
- i-STAT Business
- Companion Diagnostic Testing
- Liquid Biopsy
- COVID-19
- AGILENT TECHNOLOGIES
- Table 14-3: Agilent Revenue History Diagnostics and Genomics, 2017-2022 ($ million)
- Genomics
- Cytogenetic Analysis
- Sequencing
- CRISPR
- Flow Cytometry
- Companion Diagnostics - Dako
- COVID-19
- BECKMAN COULTER BECKMAN COULTER, INC. / DANAHER
- Table 14-4: Beckman Coulter Revenue History, 2017-2022 ($ million, estimated)
- Table 14-5: Beckman Coulter Diagnostic Revenues by Segment, 2019-2022 ($ million) est
- Hematology
- Hematology IT
- Clinical Chemistry
- Immunoassays
- Microbiology
- IT Clinical
- Flow Cytometry
- Blood Banking
- Beckman Coulter Life Sciences
- COVID-19
- BECTON, DICKINSON AND COMPANY (BD)
- Table 14-6: BD Revenue History, 2017-2022 ($ million, estimated) FYE Sept 30
- Table 14-7: BD Diagnostic Revenues by Segment, 2017-2022 ($ million)
- Cytology
- Molecular Microbiology
- Traditional Microbiology - ID/AST
- Blood Culture
- Hospital Acquired Infections
- Blood Collection
- Mass Spectrometry
- Flow Cytometry
- COVID-19
- BIOMÉRIEUX INC.
- Table 14-8: bioMérieux Revenue History, 2017-2022 ($ million)
- Table 14-9: bioMérieux Diagnostic Revenues by Segment, 2017-2022 ($ million)
- Traditional Microbiology
- Blood Culture
- Immunoassays
- Mass Spectrometry
- BIOFIRE Diagnostics Business
- Expansion
- COVID-19
- BIO-RAD LABORATORIES, INC.
- Table 14-10: BioRad Revenue History, 2017-2022 ($ million, estimated)
- Table 14-11: Bio-Rad Diagnostic Revenues by Segment ($ million) est
- Quality Control
- Blood Bank
- Diabetes
- Immunoassays
- Liquid Biopsy
- Droplet Digital PCR
- Sequencing
- COVID-19
- CEPHEID / DANAHER
- Table 14-12: Cepheid Revenue History, 2017-2022 ($ million, clinical product sales)
- GeneXpert/ Xpress Line
- Tuberculosis
- Microbiology
- POC Testing
- Cancer
- COVID-19
- DANAHER CORPORATION
- Table 14-13: Danaher Revenue History, 2017-2022 ($ million, Diagnostics, estimated)
- Acquisitions
- DEXCOM
- Table 14-14: Dexcom Revenue History, 2017-2022 ($ million)
- DIASORIN S.P.A
- Table 14-15: DiaSorin Revenue History, 2017-2022 ($ million)
- Development Plan
- Expansion
- Immunoassays
- Molecular
- Molecular Oncology
- COVID-19
- EXACT SCIENCES
- Table 14-16: Exact Sciences Revenue History, 2017-2022 (in $ millions)
- COVID-19
- HOLOGIC, INC.
- Table 14-17: Hologic Revenue History estimated diagnostic product revenue, 2017-2022 ($ million, estimated)
- Table 14-18: Hologic Diagnostic Revenues by Segment, 2017-2022 ($ million)
- Acquisitions
- PANTHER Molecular System
- HIV Testing
- Sexually Transmitted Infections
- Infectious Diseases
- Panther Fusion
- Cytology
- COVID-19
- ILLUMINA
- Table 14-19: Illumina Revenue History, 2017-2022 ($ million – not all revenues are for clinical products and services; estimated)
- Table 14-20: Illumina Diagnostic Revenues by Segment, 2017-2022 ($ million) est
- China
- COVID-19
- INSTRUMENTATION LABORATORY (IL) / WERFEN
- Table 14-21: Recent Revenue History, 2017-2022 ($ million, estimated)
- Table 14-22: IL Diagnostic Revenues by Segment, 2017-2022 ($ million)
- Expansion
- Coagulation
- Acute Care
- Information Technology
- LEICA BIOSYSTEMS/DANAHER
- Table 14-23: Leica Revenue History, 2017-2022 ($ millions) estimated
- Digital Pathology
- Companion Diagnostics
- Stain Reagents
- Lab Systems
- Sample Handling
- Circulating Tumor Cells (CTCs)
- Artificial Intelligence
- COVID-19
- MINDRAY - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
- NATERA
- Table 14-24: Natera Revenue History, 2017-2022 ($ millions)
- QIAGEN
- Table 14-25: QIAGEN Revenue History, 2017-2022 ($ million)
- Table 14-26: QIAGEN Diagnostic Revenues by Segment, 2017-2022 ($ million) est
- Tuberculosis
- Molecular Expansion
- Precision Medicine / Companion Diagnostics
- Molecular Microbiology
- Prenatal Testing
- Next Generation Sequencing
- Sample Prep, Informatics
- Digital PCR
- Liquid Biopsy
- Cervical Cancer
- Expansion
- COVID-19
- QUIDELORTHO CORPORATION
- Table 14-27: QuidelOrtho Revenue History, 2018-2022 ($ million)
- Table 14-28: QuidelOrtho Diagnostic Revenues by Segment, 2020-2022 ($ million) est
- Immunoassays
- Rapid Immunoassays
- The Solana Business
- Molecular – Savanna
- Blood Bank
- COVID-19
- RADIOMETER A/S / DANAHER
- Table 14-29: Radiometer A/S Revenue History, 2017-2022 (estimated, $ million)
- Critical Care
- Immunoassays
- HemoCue
- Transcutaneous Monitoring
- ROCHE DIAGNOSTICS
- Table 14-30: Roche Revenue History, 2017-2022 (in millions $)
- Table 14-31: Roche Diagnostic Revenues by Segment, 2017-2022 ($ million) est
- Hematology
- Immunoassays
- HIV
- Molecular Expansion
- Core Molecular
- Digital PCR
- Diabetes Care
- Coagulation
- cobas Liat System – POC
- HPV
- Blood Bank
- Transplant Medicine
- Cancer Companion Testing
- IT in Anatomical Pathology
- Information Technology
- COVID-19
- SIEMENS HEALTHINEERS (SIEMENS)
- Table 14-32: Siemens Healthineers Revenue History, 2017-2022 ($ million, estimated)
- Table 14-33: Siemens Healthineers Diagnostic Revenues by Segment, 2021-2022 ($ million)
- Core Lab
- Lab Automation
- Immunoassays
- Hematology
- Urinalysis
- Molecular
- Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
- Sequencing with Artificial Intelligence
- Acute Care – POC
- POC Connectivity
- Business Expansion
- COVID-19
- SYSMEX CORPORATION
- Table 14-34: Sysmex Revenue History, 2018-2022 ($ million) FYE March 31
- Table 14-35: Sysmex Diagnostic Revenues by Segment, 2018-2022 ($ million) est
- Hematology
- Coagulation
- Urinalysis and Infectious Disease
- Immunoassays
- Lab Information System
- Information Technology
- Flow Cytometry
- Precision Medicine / Companion Test Diagnostics
- Liquid Biopsy
- Oncology
- Sysmex Inostics
- Forging New Markets
- COVID-19
- THERMO FISHER SCIENTIFIC INC.
- Table 14-36: Thermo Fisher Revenue History, 2017-2022 (clinical diagnostics, $ million)
- Table 14-37: Thermo Fisher Scientific Diagnostic Revenues by Segment, 2017-2022 ($ million)
- Immunoassays
- Microbiology
- Molecular Test Business
- Next Generation Sequencing
- qPCR
- Oncology Companion Diagnostics
- Transplant Medicine
- Microbiome
- Mass Spectrometry
- Collaborations
- Gene Editing and Cell Therapy
- China
- COVID-19
- VENTANA MEDICAL SYSTEMS INC. / ROCHE TISSUE DIAGNOSTICS
- Table 14-38: Ventana Medical Systems Revenue History, 2017-2022 ($ millions)
- Immunohistochemistry - IHC
- Cervical Cancer Screening
- Companion Diagnostics
- WERFEN
- Table 14-39: Werfen Recent Revenue History, 2017-2022 ($ million estimated)
- CHAPTER FIFTEEN: COMPANY PROFILES: THE SECOND TIER
- BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE)
- Table 15-1: BGI Genomics Revenue History, 2017-2022 ($ millions)
- PCR and Fluorescence
- MGI Tech Co., Limited, China
- Prenatal Testing
- Test Services
- Whole Genome Sequencing (WGS)
- NGS Sequencing
- Collaborations
- COVID-19
- BIOCARTIS
- Table 15-2: Biocartis Revenue History, 2017-2022 ($ million)
- COVID-19
- BRUKER CORPORATION
- Table 15-3: Bruker Revenue History Product revenue, 2017-2022 ($ million)
- Acquisitions and Collaborations
- Mass Spectrometry
- Microbiology
- Molecular PCR
- COVID-19
- DIAGNOSTICA STAGO S.A.S.
- EIKEN CHEMICAL CO., LTD
- Table 15-4: Eiken Chemical Revenue History, 2017-2022 ($millions) FYE March 31
- Product News
- COVID-19
- FULGENT GENETICS, INC
- Table 15-5: Fulgent Revenue History, 2017-2022 ($ million)
- COVID-19
- FUJIREBIO DIAGNOSTICS, INC.
- Table 15-6: Fujirebio Diagnostics Revenue History, 2017-2022 ($ millions) FYE March 31
- GRIFOLS S.A.
- Table 15-7: Grifols Revenue History ($ million)
- Table 15-8: Grifols Diagnostic Revenues by Segment ($ million)
- Blood Transfusion Business
- ABO Blood Typing
- Molecular ABO Blood Typing
- Immunoassays
- Market Expansion
- Self-Testing
- COVID-19
- GUARDANT HEALTH, INC.
- Table 15-9: Guardant Health Revenue History, 2019-2022 ($ million)
- HORIBA MEDICAL
- Table 15-10: Horiba Medical Revenue History, 2017-2022 (in millions USD) (medical diagnostic sales)
- INVITAE
- MASIMO CORPORATION
- Table 15-11: Masimo Revenues History, 2017-2022 ($ millions)
- MENARINI DIAGNOSTICS
- COVID-19
- MERIDIAN BIOSCIENCE, INC.
- Table 15-12: Meridian Bioscience Revenue History, 2017-2022 ($ million, estimated) FYE Sept 30
- Immunoassays
- Molecular Tests
- COVID-19
- MYRIAD GENETICS, INC.
- Table 15-13: Myriad Genetics Revenue History, 2017-2022 ($ millions) FYE June 30
- NIHON KOHDEN
- Table 15-14: Nihon Kohden Revenues History, 2017-2022 ($ millions)
- ORASURE TECHNOLOGIES, INC.
- Table 15-15: OraSure Technologies Revenue History, 2017-2022 ($ million)
- Table 15-16: OraSure Technologies Product Revenue History, 2020-2022 ($ million)
- COVID-19
- PERKINELMER, INC. ( REVVITY)
- Table 15-17: PerkinElmer Revenue History, 2017-2022 ($ million, estimated)
- Table 15-18: PerkinElmer Diagnostic Revenues by Segment, 2017-2022 ($ million) est
- Diagnostics
- Sequencing /Genomics
- Liquid Biopsy
- Histology
- Prenatal Business
- Lab Services
- Mass Spectrometry
- COVID-19
- SEKISUI DIAGNOSTICS LLC
- COVID-19
- VERACYTE, INC.
- Table 15-19: Veracyte Revenue History (in $ millions)
- CHAPTER SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
- CERUS CORPORATION
- Table 16-1: Cerus Revenue History ($ million)
- COVID-19
- QUOTIENT LIMITED (ALIVEDX)
- COVID-19
- CHAPTER SEVENTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES
- AB SCIEX PTE LTD.
- ARKRAY
- Dry Chemistry / Immunoassays
- Urinalysis
- Diabetes
- Molecular
- EKF DIAGNOSTICS HOLDINGS PLC
- Table 17-1: EKF Diagnostics Revenue History ($ millions)
- COVID-19
- ELITECH GROUP S.A.S.
- COVID-19
- SHIMADZU SCIENTIFIC INSTRUMENTS
- SNIBE CO. LTD., (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.)
- COVID-19
- TOSOH BIOSCIENCE
- COVID-19
- TRINITY BIOTECH PLC
- Table 17-2: Trinity Biotech Revenue History, 2017-2022 ($ millions)
- COVID-19
- CHAPTER EIGHTEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
- BIOCEPT, INC.
- COVID-19
- BIODESIX
- COVID-19
- EPIC SCIENCES
- EPIGENOMICS AG
- FOUNDATION MEDICINE, INC.
- MENARINI-SILICON BIOSYSTEMS
- COVID-19
- NEOGENOMICS
- CHAPTER NINETEEN: COMPANY PROFILES: SPECIALISTS
- ASCENSIA DIABETES CARE HOLDINGS AG
- BIGFOOT BIOMEDICAL INC.
- DEBIOTECH SA
- COVID-19
- GLOOKO INC.
- INSULET CORPORATION
- Table 19-1: Insulet Corp Revenue History ($ million)
- INTEGRITY APPLICATIONS INC. (GLUCOTRACK)
- LIFESCAN INC.
- MEDTRONIC PLC
- Table 19-2: Medtronic Revenue History, 2017-2022 ($ million)
- NEMAURA MEDICAL INC.
- COVID-19
- VERILY LIFE SCIENCES LLC
- COVID-19
- CHAPTER TWENTY: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) AND COAGULATION SPECIALISTS
- CELLAVISION AB
- NOVA BIOMEDICAL CORPORATION (NOVA)
- CHAPTER TWENTY-ONE: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
- AMOY DIAGNOSTICS CO. LTD.
- APPLIED SPECTRAL IMAGING INC. (ASI)
- BIOGENEX LABORATORIES, INC.
- BIOVIEW LTD.
- LEICA BIOSYSTEMS
- COVID-19
- MILLIPORESIGMA
- VISIOPHARM
- CHAPTER TWENTY-TWO: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS
- BIOHIT HEALTHCARE
- BIOMERICA INC.
- Table 22-1: Biomerica Revenue History, 2017-2022 ($ million)
- COVID-19
- BIO-TECHNE CORPORATION
- Table 22-2: Bio-Techne Revenue History, 2017-2022 ($ million)
- COVID-19
- EUROBIO SCIENTIFIC
- COVID-19
- EUROIMMUN AG (REVVITY)
- COVID-19
- IMMUNODIAGNOSTIC SYSTEMS (IDS)
- COVID-19
- INOVA DIAGNOSTICS, INC.
- COVID-19
- ONE LAMBDA, INC
- RESPONSE BIOMEDICAL CORP.
- COVID-19
- THERADIG
- COVID-19
- VOLITIONRX LIMITED
- COVID-19
- CHAPTER TWENTY-THREE: INFORMATION TECHNOLOGY SPECIALISTS IN IN VITRO DIAGNOSTICS
- CERNER CORP. (ORACLE)
- DELL TECHNOLOGIES INC.
- EUFORMATICS OY
- GENOMONCOLOGY LLC
- GOOGLE LLC (VERILY LIFE SCIENCES)
- INTEL CORPORATION
- INTERNATIONAL BUSINESS MACHINES CORP. (IBM)
- PHILIPS (ROYAL PHILIPS)
- Table 23.1: Philips Revenue History ($ millions)
- Histology
- Precision Medicine
- Precision Medicine IT
- Patient Monitoring
- Point of Care
- Wearable Self Monitor
- PIERIANDX (VELSERA)
- SOPHIA GENETICS SA
- COVID-19
- CHAPTER TWENTY-FOUR: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
- ACCELERATE DIAGNOSTICS, INC.
- Table 24-1: Accelerate Diagnostics Revenue History, 2017-2022 ($ thousands)
- COVID-19
- ADVANCED BIOLOGICAL LABORATORIES, S.A. (ABL)
- COVID-19
- ALTONA DIAGNOSTICS
- COVID-19
- ARCDIA INTERNATIONAL OY LTD.
- COVID-19
- BIOFIRE DIAGNOSTICS, LLC. (ACQUIRED BY BIOMÉRIEUX)
- COVID-19
- COPAN ITALIA S.P.A. AND COPAN DIAGNOSTICS, INC.
- COVID-19
- CURETIS
- COVID-19
- GENETIC ANALYSIS AS
- COVID-19
- GREINER BIO-ONE INTERNATIONAL GMBH
- MAST GROUP
- COVID-19
- MOBIDIAG
- COVID-19
- Q-LINEA AB
- OPGEN, INC.
- COVID-19
- SEEGENE, INC.
- COVID-19
- T2 BIOSYSTEMS
- COVID-19
- CHAPTER TWENTY-FIVE: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS
- ENZO BIOCHEM INC.
- Table 25-1: Enzo Biochem Revenue History, 2017-2022 ($ million)
- COVID-19
- FLUIDIGM CORPORATION (STANDARD BIOTOOLS)
- Table 25-2: Standard BioTools Revenue History, 2017-2022 ($ million)
- COVID-19
- GENOME DIAGNOSTICS BV (GENDX)
- NANOSTRING TECHNOLOGIES, INC.
- Table 25-3: NanoString Revenue History ($ million)
- COVID-19
- PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO)
- Table 25-4: PacBio Revenue History ($ million)
- COVID-19
- RANDOX LABORATORIES LTD.
- Clinical Chemistries
- POC
- Controls
- Evidence Series - Multistat Biochip Analyzers
- Molecular
- COVID-19
- TAKARA BIO INC.
- COVID-19
- VELA DIAGNOSTICS
- COVID-19
- CHAPTER TWENTY-SIX: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS
- ABINGDON HEALTH LTD.
- COVID-19
- BINX HEALTH
- COVID-19
- BIOMEME, INC.
- COVID-19
- CHEMBIO DIAGNOSTIC SYSTEMS, INC.
- Table 26-1: Chembio Diagnostics Revenue History, 2017-2022 ($ million)
- COVID-19
- CUE HEALTH
- Table 26-2: Cue Health Revenue History, 2017-2022 ($ million)
- Test to Treat
- COVID-19
- DIAZYME
- COVID-19
- DNA ELECTRONICS LTD (DNAE)
- GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS)
- Table 26-3: genedrive Revenue History, 2020-2022 (in $ millions)
- COVID-19
- NUGENEREX DIAGNOSTICS (HDS)
- IMMUNOSTICS, INC.
- COVID-19
- LOOP MEDICAL
- MEDMIRA, INC.
- Table 26-4: MedMira Revenue History, 2017-2022 ($ thousands)
- COVID-19
- QUANTUMDX GROUP, LTD.
- COVID-19
- RHEONIX, INC.
- COVID-19
- VEREDUS LABORATORIES PTE LTD
- COVID-19
- CHAPTER TWENTY-SEVEN: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS
- BERRY GENOMICS CO. LTD.
- COOPERGENOMICS (DIVISION OF COOPERSURGICAL)
- INEX INNOVATE
- COVID-19
- OXFORD GENE TECHNOLOGY
- SEQUENOM, INC. (INTEGRATED GENETICS)
- YOURGENE HEALTH
- COVID-19
- CHAPTER TWENTY-EIGHT: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS
- 10X GENOMICS
- AGENA BIOSCIENCE, INC.
- COVID-19
- BIOTYPE DIAGNOSTIC GMBH
- COVID-19
- DXTERITY DIAGNOSTICS INC.
- COVID-19
- HORIZON DISCOVERY GROUP PLC
- INCELLDX
- LGC SERACARE LIFE SCIENCES, INC.
- COVID-19
- PREANALYTIX GMBH
- PRECIPIO, INC. (FORMERLY TRANSGENOMIC)
- COVID-19
- QUANTERIX CORPORATION
- COVID-19
- STRECK INC.
- CHAPTER TWENTY-NINE: TEST SERVICE PROVIDERS
- 23ANDME
- AGENDIA BV
- AMBRY GENETICS
- COVID-19
- ARUP LABORATORIES
- COVID-19
- ASPIRA WOMEN’S HEALTH ( FORMERLY VERMILLION INC.)
- Table 29-1: Aspira Women’s Health Revenue History, 2017-2022 (in $ millions)
- BIOREFERENCE LABORATORIES
- COVID-19
- BIOTHERANOSTICS
- BLUEPRINT GENETICS OY
- BOSTON HEART DIAGNOSTICS
- CAREDX, INC.
- Table 29-2: CareDx Revenue History, 2017-2022 ($ in thousands)
- HELOMICS CORPORATION
- LABCORP, LABORATORY CORPORATION OF AMERICA
- Table 29-3: Labcorp Revenue History, 2017-2022 ($ millions)
- Precision Medicine
- Diagnostics Services
- DTC Home Testing
- Collaborations and Expansion
- COVID-19
- MAYO CLINIC LABORATORIES
- MDXHEALTH SA
- Table 29-4: MDxHealth Revenue History, 2017-2022 (in $ millions)
- OPKO DIAGNOSTICS
- Table 29-5: OPKO Diagnostics Revenue History, 2017-2022 (in $ millions)
- COVID-19
- QUEST DIAGNOSTICS
- Table 29-6: Quest Diagnostics Revenue History, 2017-2022 ($ million)
- Diagnostic Services
- Oncology
- Infectious Diseases
- Prenatal and Women’s Health
- Retail / Consumer Health
- Expansion
- COVID-19
- SONIC HEALTHCARE
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